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临床试验/NCT02057367
NCT02057367已完成4 期

The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled

Chiang Mai University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Intraoperative opioid consumption

研究概览

简要总结

Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

详细描述

Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

A Prospective Randomized Double Blind Control

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have supratentorial brain tumor
  • Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
  • Patients have been general anesthetized with endotracheal intubation and control ventilation
  • Patients who have provided consent for the participation in the research and for the use of their medical record in research

排除标准

  • Pregnant patients
  • Patients who have a history of local anesthetic allergy and/ or anaphylaxis

研究组 & 干预措施

Scalp block with 0.5% plain marcaine

Experimental

Anterior scalp block with 0.5% plain Marcaine 20 ml.

干预措施: Scalp block with 0.5% plain Marcaine (Drug)

Scalp block with 0.9% normal saline

Placebo Comparator

Anterior scalp block with 0.9% normal saline 20 ml.

干预措施: Scalp block with 0.9% normal saline (Drug)

结局指标

主要结局

Intraoperative opioid consumption

时间窗: During the supratentorial craniotomy surgery

The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.

次要结局

  • Heart rate change(within 5 minutes after skull pin insertion)
  • systolic blood pressure change(within 5 minutes after skull pin insertion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pathomporn Pin on, M.D.

Department of Anesthesiology

Chiang Mai University

研究点 (1)

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